US biotech company Advanced Cell Technology said Monday it was cleared by the government to start its second trial using human embryonic stem cells to treat blindness, this time in older people.
The trial will examine the therapy’s ability to safely treat people with a condition known as dry age-related macular degeneration, the most common form of irreversible vision loss in people over age 60.
There is currently no cure for the disease, which affects around 10-15 million Americans and another 10 million people in Europe, the company said.
The Food and Drug Administration cleared the Massachusetts-based company in November to begin a similar trial on patients with a less common form of juvenile vision loss, known as Stargardt’s disease.
“ACT is now the first company to receive FDA clearance for two hESC (human embryonic stem cell) trials, and is now a true translational leader in the field of regenerative medicine,” said chief executive Gary Rabin.
“It marks a major step forward, not just within the stem cell sector, but, potentially for modern healthcare techniques.”
The company hopes to begin the US clinical trials in the coming months, and intends to seek approval for similar trials in Europe. The US and European market for such a treatment amounts to 25 to 30 billion dollars, it said.
“We are moving ahead aggressively to seek regulatory clearance from the European Medicines Agency to conduct clinical trials in Europe,” said Edmund Mickunas, ACT?s Vice President of Regulatory Affairs.
ACT’s announcement marks the third such trial of embryonic stem cells in human patients, after US company Geron broke new ground in October last year with the first-ever attempt to use the therapy on a human patient with spinal cord injury.
Embryonic stem cell research has been a controversial field ever since the first such stem cells were isolated more than 12 years ago. Critics oppose the research because it involves the destruction of human embryos.
However scientists say the cells offer great promise in treating Parkinson’s disease, diabetes and a variety of other illnesses.
Like the other trials involving human patients, the first step in ACT’s Phase I and II trials is to assess whether the therapy is safe before moving on to testing how well it works.
Bob Lanza, chief scientist at ACT, said that trials using the technique on animals have shown no evidence of complication or tumors.
“In a rat model of macular degeneration, we have seen a remarkable improvement in visual performance over untreated animals, without any adverse effects,” said Lanza.
Twelve patients will enroll in the study at various US sites including the University of California, Los Angeles (UCLA) and Stanford University.
The therapy uses retinal pigment epithelial (RPE) cells derived from human embryonic stem cells to replace RPE cells that have broken down in patients with the disease.
Dry age-related macular degeneration, the type that occurs in 90 percent of cases, causes a deterioration in central vision when RPE cells in the patient’s macula, in the center of the retina, lose their ability to function.
Patients often experience blurring in the center of their field of vision, while peripheral view remains intact.
Dry AMD gets progressively worse, while the other type, known as wet AMD, does not advance in stages. Wet AMD is caused by abnormal blood vessels which leak fluid behind the macula, causing a quicker loss of central vision.
“As the population ages, the incidence of AMD is expected to double over the next 20 years, further exacerbating this unmet medical need,” Lanza said.
Maddow reveals how one state stood up to Trump’s USPS cuts — and won
MSNBC anchor Rachel Maddow's opening segment on Friday focused on a positive story of political pressure stopping one of the Trump administration's attacks on the U.S. Postal Service.
Maddow reported how NBC Montana reporter Maritsa Georgiou had doggedly reported on the removal of postal boxes in Missoula, where she is based. Missoula has been a long-time Democratic Party stronghold.
Montana has a competitive U.S. Senate election in 2020, with Democratic Gov. Steve Bullock challenging first-term Republican Sen. Steve Daines.
As Georgiou chased the story, she learned there were also plans to remove boxes in the battleground of Billings. And more planned for the blue town of Bozeman. And other towns.
Pepsi joins the chorus of people dunking on Tucker Carlson over Kamala Harris
The Pepsi soda company mocked Fox News personality Tucker Carlson on Friday evening.
On Tuesday, Carlson flipped out after a guest attempted to teach him how to pronounce the name of Sen. Kamala Harris (D-CA), who is running for vice president on Joe Biden's ticket.
Video of the exchange was posted on Twitter by Nikki McCann Ramirez, a researcher at the watchdog group Media Matters for America.
Tucker Carlson loses it when a guest corrects his pronunciation of Kamala Harris's name pic.twitter.com/1fHIrPGuwN
Chad Wolf’s authority is ‘illegitimate’: Hispanic Caucus chairman demands DHS chief ‘resign in disgrace’
Immigrant rights groups and Texas Democrats are urging a review on the legality of Trump administration immigration policies after a government watchdog found two of the White House’s top immigration officials are not legally eligible to serve in their respective positions.
The Government Accountability Office on Friday determined that Chad Wolf, acting Department of Homeland Security secretary, and Ken Cuccinelli, a senior official performing deputy secretary duties, aren’t legally qualified to hold those posts.
United We Dream, an advocacy group pushing for immigration reform, said the GAO’s conclusion calls into question the latest guidance from the DHS on the Obama-era Deferred Action for Childhood Arrivals, or DACA, program that was initiated in 2012.